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Applying non-animal strategies for assessing skin sensitisation report from an EPAA/cefic-LRI/IFRA Europe cross sector workshop, ECHA helsinki, February 7th and 8th 2019.
Regulatory Toxicology and Pharmacology ( IF 3.0 ) Pub Date : 2019-10-03 , DOI: 10.1016/j.yrtph.2019.104477
David Basketter 1 , Philippe Azam 2 , Silvia Casati 3 , Marco Corvaro 4 , Janine Ezendam 5 , Peter Griem 6 , Bruno Hubesch 7 , Amaia Irizar 8 , Petra Kern 9 , Irene Manou 10 , Annette Mehling 11 , Laura H Rossi 12
Affiliation  

Four years on since the last cross sector workshop, experience of the practical application and interpretation of several non-animal assays that contribute to the predictive identification of skin sensitisers has begun to accumulate. Non-animal methods used for hazard assessments increasingly are contributing to the potency sub-categorisation for regulatory purposes. However, workshop participants generally supported the view that there remained a pressing need to build confidence in how information from multiple methods can be combined for classification, sub-categorisation and potency assessment. Furthermore, the practical experience gained over the last few years, highlighted the overall high potential value of using the newly validated methods and testing strategies, but also that limitations for certain substance/product classes may become evident with further use as had been the case with other new regulatory methods. As the available information increases, review of the data and collated experience could further determine strengths and limitations leading to more confidence in their use. Finally, the need for a substantial and universally accepted dataset of non-sensitisers and substances of different sensitising potencies, based on combined human and in vivo animal data for validation of methods and test strategies was re-emphasised.

中文翻译:

2019年2月7日至8日,在ECHA赫尔辛基举行的EPAA / cefic-LRI / IFRA欧洲跨部门研讨会上,采用非动物策略评估皮肤致敏性报告。

自上一届跨部门研讨会以来的四年中,已经积累了一些实际应用和对几种非动物实验的解释的经验,这些经验有助于皮肤敏化剂的预测鉴定。用于危害评估的非动物方法正越来越多地为监管目的而对效能子类别做出贡献。但是,研讨会的与会者普遍支持这样一种观点,即迫切需要建立信心,即如何将多种方法的信息结合起来进行分类,子分类和效能评估。此外,最近几年的实践经验突显了使用最新验证的方法和测试策略的整体潜在价值,而且,对于某些物质/产品类别的限制可能会随着进一步使用而变得显而易见,就像其他新的监管方法一样。随着可用信息的增加,对数据和经过整理的经验的审查可能会进一步确定优势和局限性,从而使人们对它们的使用更有信心。最后,再次强调了需要大量的,普遍接受的非敏化剂和具有不同敏化作用力的物质的数据集,该数据集是基于人和体内动物数据的组合来验证方法和测试策略的。
更新日期:2019-10-03
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